Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23779 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR 

Section 

No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total 29,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3.—THIRD PARTY DISCLOSURE REQUIREMENTS1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosure Total Hours 

21 CFR 107.10(a) and 107.20 5 13 65 8 520 

1There are no capital costs or operating and maintenance costs associated with this collection of information 

In compiling these estimates, FDA 

consulted its records of the number of 

infant formula submissions received in 

the past. All infant formula submissions 

to FDA may be provided in electronic 

format. The hours per response 

reporting estimates are based on FDA’s 

experience with similar programs and 

information received from industry. 

FDA estimates that it will receive 13 

reports from 5 manufacturers annually 

under section 412(d) of the act, for a 

total annual response of 65 reports. Each 

report is estimated to take 10 hours per 

response for a total of 650 hours. FDA 

also estimates that it will receive one 

notification under § 106.120(b). The 

notification is expected to take 4 hours 

per response, for a total of 4 hours. 

For exempt infant formula, FDA 

estimates that it will receive two reports 

from three manufacturers annually 

under § 107.50(b)(3) and (b)(4), for a 

total annual response of six reports. 

Each report is estimated to take 4 hours 

per response for a total of 24 hours. FDA 

also estimates that it will receive one 

notification under § 107.50(e)(2). The 

notification is expected to take 4 hours 

per response, for a total of 4 hours. 

FDA estimates that 5 firms will 

expend approximately 20,000 hours per 

year to fully satisfy the record keeping 

requirements in § 106.100. It is 

estimated that 3 firms will expend 

approximately 9,000 hours per year to 

fully satisfy the record keeping 

requirements in § 107.50(c)(3). 

FDA estimates that compliance with 

the labeling requirements of §§ 107.10(a) 

and 107.20 will require 520 hours 

annually by 5 manufacturers. 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10360 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0507] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements for 

Submission of Labeling for Human 

Prescription Drugs and Biologics in 

Electronic Format 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 3, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0530. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

Elizabeth.Berbakos@fda.hhs.gov, 301– 

796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Requirements for Submission of 

Labeling for Human Prescription Drugs 

and Biologics in Electronic Format— 

OMB Control Number 0910–0530— 

Extension 

FDA is requesting that OMB extend 

approval under the Paperwork 

Reduction Act (44 USC 3501–3520) for 

the information collection resulting 

from the requirement that the content of 

labeling for prescription drug products 

be submitted to FDA electronically in a 

form that FDA can process, review, and 

archive. This requirement was set forth 

in the final rule entitled ‘‘Requirements 

for Submission of Labeling for Human 

Prescription Drugs and Biologics in 

Electronic Format’’ (December 11, 2003; 

68 FR 69009), which amended FDA 

regulations governing the format in 

which certain labeling is required to be 

submitted for FDA review with new 

drug applications (NDAs) (21 CFR 

314.50(l)(1)(i)), including supplemental 

NDAs, abbreviated new drug 

applications (ANDAs) (21 CFR 

314.94(d)(1)(ii)), including 

supplemental ANDAs, and annual 

reports (21 CFR 314.81(b)(2)(iii)(b)) (the 

final rule also applied to certain 

Biologics License Applications, but the 

information collection for these 

requirements is not part of this OMB 

approval request). 

This OMB approval request is only for 

the burden associated with the 

electronic submission of the content of 

labeling. The burden for submitting 

labeling as part of NDAs, ANDAs, 

supplemental NDAs and ANDAs, and 

annual reports, has been approved by 

OMB under Control Number 0910–0001. 

When we last requested that OMB 

extend approval for this information 

collection (see the Federal Register of 

March 29, 2006 (71 FR 15752)), we 

received several comments. Generally, 

mstockstill on DSKH9S0YB1PROD with NOTICES

23780 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 

the comments said that, unlike FDA’s 

December 11, 2003, final rule, the 

agency has now identified Extensible 

Markup Language (XML) as the required 

file format for Structured Product Label 

documents (SPL), and that the burden 

hours and costs that were calculated in 

the final rule were based on the 

submission of the content of labeling in 

PDF (portable document format). The 

comments said that the burden estimate 

in the March 29, 2006, Federal Register 

notice does not take into account the 

amount of time required to obtain, 

install, and update the program required 

to create the electronic files in the new 

format, and that SPL is a relatively new 

format requiring an initial investment in 

software, training, and process change 

that cannot simply be converted from 

the Word or PDF version of labeling. 

The comments said that the process for 

creating the SPL labeling includes 

significant effort in mapping, coding, 

recreation of the file, and quality 

control. 

In the December 13, 2006, Federal 

Register (71 FR 74924), we said that we 

will respond to the comments as soon 

as we have gathered sufficient 

information to address the costs 

specified in the comments, and that the 

public will have an opportunity to 

comment on the response at that time. 

The burden hours and costs associated 

with making these submissions using 

the SPL standard are discussed here. 

We estimate that it should take 

applicants approximately 1.25 hours to 

convert the content of labeling from 

Word or PDF to SPL format. The main 

task involved in this conversion is 

copying the content from one document 

(Word or PDF) to another (SPL). Over 

the past few years, several 

enhancements have been made to SPL 

authoring software which significantly 

reduces the burden and time needed to 

generate well-formed SPL documents. 

SPL authors may now copy a paragraph 

from a Word or PDF document and 

paste the text into the appropriate 

section of an SPL document. In those 

cases where an SPL author needs to 

create a table, the table text may be 

copied from the Word or PDF document 

and pasted into each table cell in the 

SPL document, eliminating the need to 

retype any information. Enhancements 

have also been made to the software for 

conversion vendors. Conversion 

software vendors have designed tools 

which will import the Word version of 

the content of labeling and, within 

minutes, automatically generate the SPL 

document (a few formatting edits may 

have to be made). 

Based on the number of content of 

labeling submissions received during 

2006, 2007, and 2008, we estimate that 

approximately 5,000 content of labeling 

submissions are made annually with 

original NDAs, ANDAs, supplemental 

NDAs and ANDAs, and annual reports 

by approximately 450 applicants. 

Therefore, the total annual hours to 

convert the content of labeling from 

Word or PDF to SPL format would be 

approximately 6,250 hours. 

Concerning costs, we continue to 

conclude that there are no capital costs 

or operating and maintenance costs 

associated with this collection of 

information. In May 2009, FDA issued 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Drug Establishment 

Registration and Listing.’’ The guidance 

describes how to electronically create 

and submit SPL files using defined code 

sets and codes for establishment 

registration and drug listing 

information, including labeling. The 

information collection resulting from 

this guidance, discussed in the Federal 

Register of January 8, 2009 (74 FR 816), 

has been approved by OMB under 

Control Number 0910–0045. As 

discussed in the January 8, 2009, 

Federal Register notice, to create an SPL 

file and submit it to FDA, a registrant 

would need the following tools: A 

computer, appropriate software, access 

to the Internet, knowledge of 

terminology and standards, and access 

to FDA’s electronic submission gateway 

(ESG). Registrants (and most 

individuals) have computers and 

Internet access available for their use. If 

a business does not have an available 

computer or access to the Internet, free 

use of computers and the Internet are 

usually available at public facilities, 

e.g., a community library. In addition, 

there should be no additional costs 

associated with obtaining the 

appropriate software. In 2008, FDA 

collaborated with GlobalSubmit to make 

available free SPL authoring software 

that SPL authors may utilize to create 

new SPL documents or edit previous 

versions. (Information on obtaining this 

software is explained in section IV.A of 

the guidance ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Drug Establishment Registration and 

Listing.’’) In addition to the software, 

FDA also provides technical assistance 

and other resources, code sets and 

codes, and data standards regarding SPL 

files. 

After the SPL file is created, the 

registrant would upload the file through 

the ESG, as explained in the January 8, 

2009, Federal Register notice. A digital 

certificate is needed to use the ESG. The 

digital certificate binds together the 

owner’s name and a pair of electronic 

keys (a public key and a private key) 

that can be used to encrypt and sign 

documents. A fee of up to $20.00 is 

charged for the digital certificate and the 

registrant may need to renew the 

certificate not less than annually. We 

are not calculating this fee as a cost for 

this extension because all applicants 

who submit content of labeling are also 

subject to the drug establishment 

registration and listing requirements 

and would have already acquired the 

digital certificate as a result of the May 

2009 guidance on drug establishment 

registration and listing. 

In the Federal Register of November 

6, 2009 (74 FR 57491), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Content of labeling submissions 

in NDAs, ANDAs, supplemental 

NDAs and ANDAs, and annual 

reports 

Number of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

450 11.11 5,000 1.25 6,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23781 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10361 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0199] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Procedures for the Clinical Laboratory 

Improvement Amendments of 1988 

Categorization 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

administrative procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) 

categorization. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 6, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

including each proposed extension an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Administrative Procedures for CLIA 

Categorization—42 CFR 493.17 (OMB 

Control Number 0910–0607–Extension) 

A guidance document entitled 

‘‘Guidance for Administrative 

Procedures for CLIA Categorization’’ was 

released on May 7, 2008. The document 

describes procedures FDA will use to 

assign the complexity category to a 

device. Typically, FDA assigns 

complexity categorizations to devices at 

the time of clearance or approval of the 

device. In this way, no additional 

burden is incurred by the manufacturer 

since the labeling (including operating 

instructions) is included in the 510(k) or 

PMA. In some cases, however, a 

manufacturer may request CLIA 

categorization even if FDA is not 

simultaneously reviewing a 510(k) or 

PMA. One example is when a 

manufacturer requests that FDA assign 

CLIA categorization to a previously 

cleared device that has changed names 

since the original CLIA categorization. 

Another example is when a device is 

exempt from premarket review. In such 

cases, the guidance recommends that 

manufacturers provide FDA with a copy 

of the package insert for the device and 

a cover letter indicating why the 

manufacturer is requesting a 

categorization (e.g. name change, 

exempt from 510(k) review). The 

guidance recommends that in the 

correspondence to FDA the 

manufacturer should identify the 

product code and classification as well 

as reference to the original 510(k) when 

this is available. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

CFR 

Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Responses Total Hours Total Operating & Maintenance Costs 

42 CFR 493.17 60 15 900 1 hr 900 hr $46,800 

1There are no capital costs associated with this collection of information. 

The number of respondents is 

approximately 60. On average, each 

respondent will request categorizations 

(independent of a 510(k) or PMA) 15 

times per year. The cost, not including 

personnel, is estimated at $52 per hour 

(52 x 900) totaling $46,800. This 

includes the cost of copying and mailing 

copies of package inserts and a cover 

letter, which includes a statement of the 

reason for the request and reference to 

the original 510(k) numbers, including 

regulation numbers and product codes. 

The burden hours are based on FDA 

familiarity with the types of 

documentation typically included in a 

sponsor’s categorization requests, and 

costs for basic office supplies (e.g. 

paper). The costs have been updated 

based on the Bureau of Labor Statistics 

estimates of inflation. 

mstockstill on DSKH9S0YB1PROD with NOTICES